Fluphenazine Enanthate Injection
» Fluphenazine Enanthate Injection is a sterile solution of Fluphenazine Enanthate in a suitable vegetable oil. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of fluphenazine enanthate (C29H38F3N3O2S).
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I or Type III glass, protected from light.
[note—Throughout the following procedures, protect test or assay specimens, the USP Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware. ]
Identification— To a volume of Injection, equivalent to about 50 mg of fluphenazine enanthate, add 2 mL of methanol and 3 mL of palladium chloride solution (1 in 1000): a rust-red color is produced. Add an excess of the palladium chloride solution: the color is intensified to a brownish red.
Other requirements— It meets the requirements under Injections 1.
Assay— Dissolve an accurately measured volume of Injection, equivalent to about 150 mg of fluphenazine enanthate, in 75 mL of glacial acetic acid, add 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 27.49 mg of fluphenazine enanthate (C29H38F3N3O2S).
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Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
USP35–NF30 Page 3250